appears up-to-date. Mr. Fauber states that opioid prescribing is high
in fibromyalgia, and statements such as this can be found but fail to
provide the research behind this assertion. This statement may not be
specifically backed up in the current scientific literature for the
United States.
In 2004 the American Pain Society released guidelines for treatment of
fibromyalgia (DL Goldberg et al) which specifically stated: =93There
have been no RCTs of opioids in patients with FMS. Opioids should be
considered only after all other medicinal and nonmedicinal therapies
have been exhausted.=94
In 2006, there was a survey of physician prescribing practices done in
the United States in 2006 (B Bhamb et al) showing opioid prescribing
in fibromyalgia, but statistics specific to fibromyalgia and/or the
specific opioids prescribed are not cited in the paper.
Since 2007 the United States FDA has approved three drugs (duloxetine,
milnacipram, pregabalin) specifically as first-line pharmacological
treatments for fibromyalgia =96 none of which are opioids. Did this
effect opioid prescribing in fibromyalgia? Mr. Fauber doesn't say.
Painkiller boom fueled by networking
Doctors, researchers with financial ties to drug makers set stage for
surge in prescriptions
By=A0John Fauber=A0of the=A0Journal Sentinel
Feb. 18, 2012=A0|
Prescriptions for narcotic painkillers soared so much over the last
decade that by 2010 enough were being dispensed to medicate every
adult in the United States around-the-clock for a month.
Behind that surge was a network of pain organizations, doctors and
researchers that pushed for expanded use of the drugs while taking in
millions of dollars from the companies that made them, a Journal
Sentinel/MedPage Today investigation found.
Last year,=A0the newspaper found=A0that a University of Wisconsin-based
organization in Madison had been a national force in helping
liberalize the way opioids are prescribed and viewed. While pushing a
pharmaceutical industry agenda that critics say was not supported by
rigorous science, the UW Pain & Policy Studies Group took in $2.5
million over a decade from opioid companies.
After the story ran in April, the=A0UW Pain group said=A0it had decided to
stop taking money from the drug industry.
But the UW group is just one link in a network of national
organizations and researchers with financial connections to the makers
of narcotic painkillers that paved the way for the boom in prescribing
drugs such as OxyContin and Vicodin.
Beginning 15 years ago, the network helped create a body of dubious
information that can be found in prescribing guidelines, patient
literature, position statements, books and doctor education courses,
all which favored drugs known as opioid analgesics.
Doctors say the increased use sprang from research that showed the
drugs were safe and effective for short-term pain, such as after
surgery, as well as cancer and end-of-life pain. Without rigorous
research, they say, those beliefs then were applied to a much larger
population of people with long-term pain, such as low back pain and
fibromyalgia.
With millions of Americans suffering real pain that can last for years
and thousands of doctors wanting to help them, it was a situation ripe
for the influence of the pharmaceutical industry, said Mark Sullivan,
a professor of psychiatry and behavioral sciences at the University of
Washington.
By 2010, those firms were selling four times as many prescription
painkillers to pharmacies, doctors' offices and hospitals than in
1999, according to the most recent data from the U.S. Centers for
Disease Control and Prevention.
Led by OxyContin, sales on prescriptions of opioid drugs totaled $8.4
billion in 2011, up from $5.8 billion in 2006, according to data
supplied by IMS Health, a drug market research firm.
"We've never really exposed so many people to so much drug for so
long," Sullivan said. "We don't really know what the long-term results
are."
A band of doctors who get little or no money from opioid makers has
begun to challenge the hype behind the drugs. They say pharmaceutical
industry clout has caused doctors to go overboard in prescribing the
drugs, leading to addiction, thousands of overdose deaths each year
and other serious complications.
Several of the pain industry's core beliefs about chronic pain and
opioids are not supported by sound research, the Journal
Sentinel/MedPage Today investigation found. Among them:
The risk of addiction is low in patients with prescriptions.
There is no unsafe maximum dose of the drugs.
The concept of "pseudoaddiction."
That concept holds those who display addictive behavior, such as
seeking more drugs or higher doses, may not be actual addicts - they
are people who need even more opioids to treat their pain.
Even some doctors who have financial relationships with companies that
make narcotic painkillers concede that the practice of pain medicine
got ahead of the science.
Lynn Webster, a Utah pain specialist who has worked as a consultant
and adviser to most of the companies that make opioids, said: "We
overshot our mark, all well-intended, I believe. We certainly have a
lot of reverse education that needs to occur."
Some chronic pain sufferers do benefit from the drugs, said Webster,
an officer of the American Academy of Pain Medicine.
"The problem is pain is complex," he said. "There is a whole family of
opioids, and we have not figured out how to best identify the
individuals who can benefit long-term.
"I don't think industry was trying to harm anyone. I think industry
was trying to fill a need that we as physicians saw."
Over the past decade, as many as 100,000 Americans have died from
opioid overdoses and millions have become addicted to the drugs, said
Andrew Kolodny, a New York psychiatrist and opioid addiction
specialist who co-founded=A0Physicians for Responsible Opioid
Prescribing.
"This is an out-of-control epidemic, not caused by a virus or a
bacteria," said Kolodny, chairman of psychiatry at=A0Maimonides=A0Medical
Center in New York. "This epidemic has been caused by a brilliant
marketing campaign that dramatically changed the way physicians treat
pain."
The pharmaceutical industry's alliance with pain groups is part of a
familiar playbook.
It has occurred with other organizations, though those financial
relationships aren't always fully disclosed, said David Rothman,
president of the Institute on Medicine as a Profession, part of
Columbia University College of Physicians and Surgeons.
The drug companies "expect a certain return for their money," he said,
"and the sad thing is, they often get it."
Maximum dose
Consider the American Pain Foundation, which has substantial financial
ties to companies that make narcotic painkillers. In a patient guide
available on its website, it says there is no ceiling dose for opioids
as long as they are not combined with other drugs such as
acetaminophen. It says the dose can gradually be increased over time
if pain worsens.
Independent doctors say that practice developed to treat the pain of
cancer patients in the hospital or at the end of life.
It should not be applied to chronic pain sufferers who are not getting
their drugs in a hospital setting, said Sullivan, the University of
Washington professor.
A philosophy of "no maximum dose" can lead to more people on high
doses of the drugs, which, in turn, can result in serious problems,
including more falls and fractures in older people, respiratory
depression, overdoses and fatalities, he said.
"Risk goes up with dose, even if it is well done," Sullivan said.
An April 2011 paper in the Archives of Internal Medicine found that
the risk of death for high-dose patients was three times greater than
in lower-dose patients.
The no-ceiling dose statement appears in the Pain Foundation's "guide
for people living in pain," a publication that received funding from
three drug companies.
Two of the companies, Purdue Pharma and Cephalon, were the subject of
U.S. Justice Department investigations involving their opioid
products.
In 2007, Purdue was accused of fraudulently misleading doctors by
claiming, with no proof, that its narcotic painkiller OxyContin was
less addictive, less likely to cause withdrawal and less subject to
abuse than other pain medications. A court imposed fines and
restitution payments totaling $635 million.
In 2008, Cephalon settled an investigation of off-label marketing of
three of its drugs, including Actiq, a powerful painkilling product
manufactured as a lollipop with the drug fentanyl. The drug was
approved for use only by cancer patients who no longer were getting
pain relief from morphine-based drugs. But Cephalon allegedly promoted
the drug for non-cancer patients with conditions ranging from
migraines to injuries. Cephalon agreed to pay a $425 million penalty.
In recent years the American Pain Foundation has received millions of
dollars from industry, including companies that market opioids. They
include Purdue, Cephalon and several other opioid companies.
Foundation officials would not be interviewed for this story.
In an email statement, Micke Brown, a registered nurse and
spokesperson for the foundation, said it stands by the statements in
its pain guide, which was developed by leading pain experts.
"APF along with many from the pain community is concerned (about) the
misuse and abuse of these valued medications. Unfortunately, the
weight of this complex problem has been placed on the backs of people
living with pain."
The full story can be read here:
http://www.jsonline.com/watchdog/watchdogreports/painkiller-boom-fueled-by-=
networking-dp3p2rn-139609053.html
John Fauber reported this story in a joint project of the Journal
Sentinel and MedPage Today. MedPage Today provides a clinical
perspective for physicians on breaking medical news at
medpagetoday.com.
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